UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037908 |
|---|---|
| Receipt number | R000043160 |
| Scientific Title | Multi-center pilot study examining a procedure to measure LFCT in heart failure patients. |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2020/02/27 09:49:40 |
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Basic information
Public title
Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Acronym
Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Scientific Title
Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Scientific Title:Acronym
Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the Lung-to-Finger Circulation Time(LFCT) measurement method, which was proved to be appropriate for healthy volunteers, is also applicable for patients with heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation in LFCT measurement
Key secondary outcomes
Rate of successful measurement of LFCT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Four times repeated LFCT measurement using holding breathing for 20 sec
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.NYHA classification I-III , in the treatment of heart failure
Key exclusion criteria
1.Patients in acute phase of cardiovascular disease (<7 days)
2.Patients who need oxygen inhalation
3.Those on whom a measurement device cannot be equipped on the second and third finger of the right hand
4.Patients with impaired understanding or recognition
5.Patients with a permanent pacemaker
6.Patients under hemodialysis
7.Patients judged by the investigator as ineligible for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Ando |
Organization
Kyushu University Hospital
Division name
Sleep Apnea Center
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5987
shinando@sleep.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Yoshioka |
Organization
Kyushu University Hospital
Division name
Sleep Apnea Center
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5988
Homepage URL
y_yasuko@sleep.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuokaken Saiseikai Futsukaichi Hospital Institutional Review Board
Address
3-13-1 Yumachi Chikushino Fukuoka prefecture
Tel
092-923-1551
info@saiseikai-futsukaichi.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学病院（東京都）、福岡県済生会二日市病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 01 | Month | 23 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043160
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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